Results of the first large-scale study examining how survival rates are affected by the use of recombinant human erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in patients with cancer showed that ESAs increased on-study mortality and worsened overall survival, confirming previous studies that have suggested that ESAs may negatively affect the overall health of these patients. The data were reported by Julia Bohlius, md, mscph, of the University of Bern, Switzerland, at the ASH meeting (abstract LBA-6).

In order to assess the effect of ESAs on mortality, a meta-analysis was conducted of 13,933 patients with cancer enrolled in 53 randomized, controlled clinical trials comparing epoetin alfa (Epogen, Procrit), epoetin beta, and darbepoetin alfa (Aranesp) plus red blood cell transfusions vs red blood cell transfusions alone for the prevention or treatment of anemia during or after receiving anticancer therapy. A total of 38 of these trials, which included 10,441 patients, used chemotherapy as the anticancer regimen.

Objectives and Results The primary endpoints of the study were on-study mortality and overall survival in patients with cancer receiving chemotherapy, including all studies where more than 70% of patients enrolled received chemotherapy, and all patients with cancer regardless of the type of anticancer therapy. On-study mortality was defined as death from any cause between the date of being randomized in the clinical trial and 28 days following the end of the treatment phase of the study. Overall survival was defined as death from any cause between the date of randomization and longest amount of follow-up available. All analyses were prespecified in a peer-reviewed protocol, and an independent steering committee agreed on all analyses and interpretations.

The study found that in all patients with cancer, the use of ESAs increased on-study mortality by 17% (hazard ratio [HR] = 1.17) and worsened overall survival by 6% (HR = 1.06). For patients undergoing chemotherapy, the increase in on-study mortality and overall survival was less pronounced (10%, HR = 1.10; and 4%, HR = 1.04, respectively). This study found that the risks associated with ESAs must be balanced against the benefits for the individual patient when treating chemotherapy-induced anemia.